CUHOP responses to Minister’s conclusion from the departmental review, The regulation of the non-medical healthcare professions

1. Regulation of the professions should be co-ordinated with the regulation of health services; build on systems used by employers (and NHS commissioners) where possible; form one integrated and consistent framework of regulation across the different professions, in which departures from the standard approach need objective justification in terms of public protection; and adopt a risk-based approach, in which any new regulatory activities must be as simple and light touch as is consistent with their patient safety goals.

A consistent framework is good but one needs to be wary of introducing a ‘one size fits all’ approach. Such could be detrimental to public protection.

Notwithstanding the foregoing comment, “defined operationalised standards against which to regulate” (Theme 2 from Healthcare Professional Regulation: Public Consultation on proposals for change) are self-evidently a necessity for regulation to work effectively and fairly. Such standards must be devised in consultation with the relevant professional bodies.

With regard to the “devolution of some regulatory activity to local level (Theme 5 from Healthcare Professional Regulation: Public Consultation on proposals for change) there is support for the proposal for closer working between the Royal Pharmaceutical Society of GB and the Pharmaceutical Society of NI. However, present health department/NHS bodies are failing to operate the principle more widely. It is anomalous, for example, that in England a pharmacist may be accredited to make emergency hormonal contraceptive supply in one PCT but not in another. Some rationalisation is needed, and in view of the existence and likely further development of postgraduate educational bodies, e.g. the Centre for Pharmacy Postgraduate Education in England, NHS Education for Scotland, the Welsh Centre for Postgraduate Pharmaceutical Education and NICPPET (Northern Ireland) these bodies could be centres for coordinating local regulatory activity. The main regulatory function should however always be located with a UK-wide regulator.

2. Regulators should be more consistent with each other about the standards they require of a person entering the register for the first time, and employers and regulators should agree on common standards as far as possible. All regulators should adopt a single definition of “good character”, one of the legal requirements for getting registration. This should be based on objective tests.

How does one objectively assess “good character”? Any such assessment must involve a degree of subjectivity and therefore leave itself open to a lack of consistency.

3. When a professional starts their first job they have to get onto a regulator’s register and satisfy the requirements of their employer. Employers and regulators should co-ordinate their information requirements so that the person provides each piece of information only once.

This makes good sense – professionals are often subject to overload in providing information.

With respect to “the need for standardised pre-employment English language testing” (Theme 9 from Healthcare Professional Regulation: Public Consultation on proposals for change), CUHOP regards this as essential for employment in a healthcare setting in the UK.

4. Revalidation is necessary for all professionals. The regulatory body needs to be in charge of setting the standard which a person must meet to stay on the register. Information already collected by the employer/commissioner should be used to meet both their and the regulator’s needs.

Agree with the principle but unsure how it will be achieved without yet another layer of bureaucracy. The Royal Pharmaceutical Society of Great Britain (and the Pharmaceutical Society of Northern Ireland) has been successful in achieving this over the years for pharmacists, without direct recourse to employers.

With regard to Theme 4 from Healthcare Professional Regulation: Public Consultation on proposals for change and its “proposals for a ‘spectrum of revalidation across all healthcare professions”, with increasing specialisation within all healthcare professions (in the case of pharmacy, supplementary and independent prescribing spring to mind) there has to be such a spectrum of revalidation.

5. The revalidation system should be both formative (an aid to development) and summative (a check that a required standard is met). Within the NHS, information gathered under the Knowledge and Skills Framework (KSF) should be the basis of revalidation. Any additional requirements should be justified by risk analysis. Professionals will fall into one of three groups for revalidation:

• employees of an approved body – revalidation carried out as part of the routine staff management or clinical governance system.

• self-employed staff providing services commissioned by NHS primary care organisations – revalidation processes built into the relevant NHS arrangements and carried out under the supervision of the commissioning organisation

• all others – regulatory bodies develop direct revalidation arrangements.

Agree with this in principle although there would need to be consistency across the different revalidation processes.

6. The Healthcare Commission in England (or its equivalent in each of the other UK countries) should approve employers who can deliver reliable revalidation processes.

Agree employers should be approved – not sure that HC is necessarily the right body to do so.

7. In addition to information from existing clinical governance systems, further information will be needed for a reliable assessment that a person remains fit to practise. This should however be proportionate and based on risk assessment.

This should not involve the professional being overburdened with paperwork, if at all possible.

8. Post-registration qualifications should be recorded in the register where the specialisation is relevant to patient care and patient safety, can be defined in terms of extra skills acquired, and is at a level substantially beyond basic registration.

This suggestion is the focus of Theme 7 from Healthcare Professional Regulation: Public Consultation on proposals for change. It is self-evidently necessary in light of existing and likely further moves to re-validation and formal specialisations.

This development should be placed firmly in the context of and allied to the expectation that healthcare professionals will not work outside their area of expertise.

At the outset, it needs to be recognised that the average member of the public will probably not be able to make proper judgements about individual practitioners based on register records. They will be of most use to other professionals, other regulators and health service managers.

9. There should be a single source of advice to those who want to express concerns about registrants and a single investigation process at local level that would provide a report and evidence that would, where possible, meet the various needs such as resolving a complaint and deciding whether to refer to a regulator. Any investigation needs to determine what actually happened.

Any investigation should also determine how a recurrence will be prevented.

10. The Council for Healthcare Regulatory Excellence (CHRE) should organise the agreement of protocols for local investigation which would ensure that their findings of fact could be relied on by regulators if a case had to go to them for resolution. Their audit role should be extended to include a duty to sample decisions taken by regulators not to proceed to formal investigation of cases referred to them.

There is agreement in principle with this extended role of CHRE but this role is likely to extract from health service providers even more resource from already overburdened budgets.

With respect to an “appropriate standard of proof” (Theme 3 from Healthcare Professional Regulation: Public Consultation on proposals for change), there is a need for consistency across the professions and across regulators.

At times the difference between measures of ‘competence’ and of ‘performance’ will have to be addressed and this is rather difficult.

11. Employers should remain ready to refer the most serious cases to the national regulator, that is, every case where investigation might lead to removal from the register.

Agree with this.

12. The task of adjudicating on concerns about impaired fitness to practise should be carried out either (a) by a single separate adjudicator for all the professions; (b) as now for the non-medical professions, or (c) under the control of regulators as now, but by shared panellists working to common standards. Comments are invited on this.

In view of the detailed knowledge of practice required for proper adjudication, separate regulators for each profession should be maintained. In pharmacy, the Royal Pharmaceutical Society of GB and the Pharmaceutical Society of NI have carried out this role successfully for many years – as evidenced by the lack of serious issues. CUHOP does not see the need to change an adjudication system that has worked and therefore supports option b. CUHOP does however have no problem with an overseeing or “ombudsman” role for CHRE.

13. Each panel hearing a case about fitness to practise would include lay and professional members; the latter selected with regard to the area in which the person appearing was working.

For each profession, it will need to be made clear who is to undertake the selection for panels and to whom they are accountable.

14. The Scottish pilot of employer-led regulation of support workers, which should provide important evidence about whether this is the best way to proceed, will continue until the end of 2006. A successful outcome for the pilot could lead to the adoption of a UK-wide employer-led approach to the regulation of this group of workers.

Caution is needed here. What works in Scotland is not always applicable to the whole of the UK. This is getting even truer over time as the NHS in Scotland and the NHS in other parts of the UK develop in their own somewhat different ways.

On the general theme of possibly “extending the scope of regulation to include healthcare support workers and new roles in healthcare (Theme 10 from Healthcare Professional Regulation: Public Consultation on proposals for change), presumably this would include various local authority care workers, in which case CUHOP would expect the local authority to have its own controls in place.

15. The new roles using the working titles of Anaesthesia Practitioner, Emergency Care Practitioner, Endoscopy Practitioner, Medical Care Practitioner and Surgical Care Practitioner need statutory regulation, if healthcare providers agree they are fit for purpose. Work remains to be done about the exact form this should take: whether they should be regulated as one group with specialisms, or as up to five separate groups.

No comment.

16. One or more existing regulators will become the “lead regulator” for new groups. The lead regulator will set the standards applying to everyone registering as a member of the new group. Where someone joins the new group from an existing profession, they can remain registered with their existing regulator and avoid costly dual registration.

No problem with the principle but wary of how it might work in practice.

17. All regulators have the same role of protecting the public. Where existing legislation adds other roles of professional leadership and promoting the profession, as for example in pharmacy, these should be explicitly and exclusively exercised for the public benefit. The implementation of changes following this review will provide opportunities to bring the regulation of these professions into line with the majority.

See views expressed in the main body of the CUHOP response to Healthcare Professional Regulation: Public Consultation on proposals for change.

Although CUHOP does not support the continued coupling of regulation and representation that the organisation embodies, the Royal Pharmaceutical Society of GB’s ‘Patient and Public Involvement Strategy’ is the type and style of initiative by a regulator or a professional body that can help maintain public confidence in the safety of healthcare professional services and in the appropriateness of their future development.

18. There are substantial areas in which common standards would be desirable – in particular most aspects of conduct. The more difficult task of identifying common educational standards in areas such as the knowledge needed to underpin safe prescribing should not be ducked either. The regulators and CHRE should work to introduce common standards in all those areas where this would benefit patient safety.

Agree in principle and particularly for skills, conduct and areas of commonality such as aspects of prescribing. It is however, difficult to see how this could apply to the broader knowledge base underpinning each profession.

19. Some or all of the elected professional members of Councils should be replaced by appointed professional members. A clear person specification is required, identifying desirable qualities. Professional majorities on each regulatory body could remain, but they should in future be made up differently, with most or all professionals appointed rather than elected.

Who does the appointing, what are their qualifications for doing so and, if professional members are not elected, to whom and by what route will they be accountable?

20. Comments are invited on the future balance of Councils between professional and lay members, with the possibility of either a professional majority of one, a lay majority of one or no change.

In pharmacy of course, there is now a greater inclusion of lay members on the Council of the Royal Pharmaceutical Society of GB than in the past. The input of lay members is valuable in avoiding introspection but in CUHOP’s view there should be, however small, a majority of professional members. It should also be pointed out that it is the quality of lay members rather than their number which determines their impact within a council and on a profession. There used only to be three Privy Council nominees on the Council of the RPSGB. Their impact was considerable because of their stature, capabilities and experience from other walks of life.

21. Changes are needed to the membership of CHRE’s Council which will preserve its lay majority (and UK-wide makeup) while securing a professional voice through appointments against objective criteria, in place of the existing ex officio membership of Regulatory Bodies’ Presidents.

Who is to make the appointments and who is to set objective criteria for their selection? This needs to be made clear.

22. A regulator like the Health Professions Council, dealing with a range of disparate professional groups, can deliver the functions which public protection requires. Professional bodies dedicated to providing leadership and setting standards are also needed: the two work together.

See views expressed in the main body of the CUHOP response to Healthcare Professional Regulation: Public Consultation on proposals for change.

23. Any new profession coming into statutory regulation should be regulated by one of the existing regulatory bodies, most likely the HPC.

Much would depend on the nature of the emergent profession in deciding to agree with this proposal. Perhaps ministers and health departments should not make this a hard and fast rule.

24. The Pharmaceutical Society of Northern Ireland (PSNI) should remain as an independent body for the time being but with shared functions with the Royal Pharmaceutical Society of Great Britain (RPSGB). In the longer term, however, the two societies should amalgamate into a single UK body, following the passage of the necessary primary legislation. At the same time any necessary changes can be made to clarify the separation of the RPSGB’s regulatory and professional lead functions. However there should be no other changes to the number of regulators at present.

With respect to pharmacy, see views expressed in the main body of the CUHOP response to Healthcare Professional Regulation: Public Consultation on proposals for change.

On the general question what is the right “number of regulators for the non-medical professions (Theme 6 from Healthcare Professional Regulation: Public Consultation on proposals for change), in view of the detailed knowledge of practice required for proper regulation, separate regulators for each profession should be maintained.

25. We will keep under review the question of whether harmonisation of the work done by the remaining regulators delivers the necessary benefits or whether this requires a further cut in the number of regulatory bodies. We will review the position after five years, in 2011. It may be that in practice the need for further structural change can be avoided by closer collaboration and harmonisation between all the remaining regulatory bodies.

It may indeed be the case that closer collaboration is possible now and would avoid (possibly very expensive) structural change in the next decade.

At least one CUHOP member explicitly demurs from this view.

November 8th 2006

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